FDA 483 - Merck Teknika LLC - January 14, 2020

Organon Teknika Corporation LLC in Durham, NC, was inspected and received a Form 483 with ten observations. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, cleaning procedures, and adherence to written procedures for sterile drug product manufacturing. Issues also included inadequate statistical procedures, computer system controls, record keeping, component identification, and warehousing practices.